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ASCENTIAL MEDICAL & LIFE SCIENCES (SINGAPORE) PTE. LTD.
is seeking a hands-on manual electro-mechanical assembler to build medical device components in a GMP environment, following approved work instructions, engineering drawings, and ISO 13485 requirements. The role requires a Technical Diploma or ITE in Mechanical Engineering, Mechatronics, or Automation, 1+ year assembling regulated devices, ability to read drawings, and good English.
Responsible for performing manual electro-mechanical assembly of medical devices within a GMP-controlled environment, ensuring all products are built, verified, and documented in accordance with approved work instructions, engineering specifications, and ISO 13485 quality requirements.
Perform manual electro-mechanical assembly of medical device components and sub-assemblies in accordance with approved work instructions, engineering drawings, and bills of materials (BOM), within a GMP-controlled environment.
Assemble mechanical, electrical, and electronic components using hand tools, torque tools, soldering/crimping equipment, and small power tools.
Perform basic wiring, cable routing, and connector assembly to specification.
Perform routine tools and equipment verification checks (e.g., torque drivers, gauges, jigs, and fixtures) prior to and during production to confirm calibration status and proper function.
Report equipment malfunctions, out-of-calibration tools, or process deviations to the Manufacturing Engineer or Quality Engineer immediately.
Maintain accurate production checklists and traveler records in real time and in full compliance with ISO 13485 best practices and applicable GMP requirements.
Complete Device History Record (DHR) documentation and lot/serial number traceability records accurately and legibly.
Perform in-process and final visual/functional inspections to verify conformance to specifications.
Identify, segregate, and document non-conforming material or product per established procedures.
Maintain a clean, organized, and GMP-compliant work area in accordance with 5S and housekeeping standards.
Technical Diploma or ITE certification in Mechanical Engineering, Mechatronics, or Automation.
1+ year(s) of hands-on assembly experience, preferably within a regulated medical device, electronics, or precision manufacturing environment.
Proficient in spoken, read, and written English.
Ability to read and interpret engineering drawings, BOMs, and work instructions.
Working knowledge of electro-mechanical assembly techniques (soldering, crimping, torque application, wiring/cable routing).
Familiarity with ISO 13485 and GMP documentation practices, including traveler records and DHR.
Competent in using and verifying hand tools, torque drivers, and precision measuring/gauging equipment.
Good manual dexterity, hand-eye coordination, and attention to detail.
Basic computer literacy for entering data into ERP/MES/QMS systems.